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Completed

NCT Number: NCT00843700

Women's Depression Treatment Study

The aim of the Women's Depression Treatment Study, based in a community mental health center, is to evaluate the effectiveness of Interpersonal Psychotherapy-Trauma in Community Settings (IPT-TCS) on improving depression and other psychological and social functioning. IPT-TCS is Interpersonal Psychotherapy with modifications specifically designed for the treatment of depressed patients with trauma histories seen in community settings.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

About this study

Evidence-based treatments for depression have rarely been studied in community settings where low-income and ethnic minority patients receive care. Among the most in need of effective treatments are depressed women with histories of early interpersonal trauma, who suffer disproportionate burden characterized by chronic depression, multiple comorbidities, and marked interpersonal difficulties. The aim of this randomized controlled trial (RCT), based in a community mental health center, is to evaluate the effectiveness of Interpersonal Psychotherapy-Trauma in Community Settings (IPT-TCS). IPT-TCS is Interpersonal Psychotherapy with modifications specifically designed for the treatment of depressed patients with trauma histories seen in community settings. This trial (n=180) will compare IPT-TCS to active treatment as usual (TAU) for women with major depression and histories of childhood sexual abuse. We hypothesize that IPT-TCS will be more effective than TAU in reducing depression at 32-weeks after treatment assignment. Improvements in social functioning, health-related functioning, post-traumatic stress symptoms, and mental health functioning are also expected. To monitor post-treatment course, outcome variables will be assessed at 6-month intervals over a 2-year period, and longer-term effects will be examined via repeated-measure analyses. This trial is designed to provide definitive results regarding the effectiveness of IPT-TCS compared to usual care in a community mental health center.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 or older
  • Current Major Depression
  • History of sexual abuse prior to age 18

Exclusion criteria

  • Bipolar disorder
  • Psychosis or schizophrenia
  • Active alcohol or substance abuse

Treatment and study plan

Interpersonal Psychotherapy-Trauma in Community Settings

Behavioral

Interpersonal Psychotherapy-Trauma in Community Settings (IPT-TCS) is Interpersonal Psychotherapy with modifications specifically designed for the treatment of depressed patients with trauma histories seen in community settings.

Treatment as Usual

Behavioral

Individual psychotherapy following usual care practice in a community mental health center.

Primary outcomes

  1. Structured Clinical Interview for DSM-IV diagnoses: Current Major Depression Module

    Time frame: 20 months

Secondary outcomes

  1. Beck Depression Inventory

    Time frame: 20 months

  2. Hamilton Rating Scale for Depression

    Time frame: 20 months

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

Effectiveness of IPT Adapted for Depressed Women With Trauma Histories in a Community Mental Health Center

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Feb 13, 2009
Registry last updated
Jan 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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